Comparison of Vitamin K Doses in Patients With Larger Burn Injuries

NCT ID: NCT03941535

Last Updated: 2021-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-10
• Study Completion Date: 2022-12-31

Brief Summary

The use of Vitamin K in treating bleeding diatheses is well documented and accepted as standard of care, as is the effect of Vitamin K on calcium and bone metabolism. In the treatment of larger burns however, there is a paucity of available literature related to optimal daily dosing, goals of therapy and potential complications. This study aims to identify any potential issues arising from the administration of a standard of care dose in an historical cohort of subjects with larger burns to a prospective patient population given a decreasing dose during their intensive care unit (ICU) stay.

Detailed Description

This will be a prospective, single-center study. Eligible subjects will present with a minimum 20% Total Body Surface Area (TBSA) burn injury and expected to receive the standard dose of intravenous Vitamin K (10mg/day). Exclusion criteria will include any patient admitted with a history of, or having present at baseline: bleeding disorders, thrombocytopenia, coagulopathy, or liver dysfunction (MELD Score ≥20). Subjects who are moribund, or in the opinion of the investigator, not expected to survive will be excluded, as well as burns induced as a result of a suicide attempt.

The study will enroll approximately 25 subjects in the prospective arm and 25 subjects will be matched from our medical record data base to the basic subject criteria for the chart review portion of the study. Study duration will be 90 days.

The research foundation will request exemption, waiver of HIPAA (Health Insurance Portability and Accountability Act) authorization and waiver of informed consent for the data collection /cohort portion of the study as only burn injury demographics, lab results and dosing regimen will be collected. No protected health information (PHI) will be recorded on patients identified for the cohort arm of the study.

Conditions

Burns

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Decreasing Daily Dose of Vitamin K

This group of patients will receive a decreasing dose of Vitamin K IV:

Days 1-2 = 10mg/day (standard of care) Days 3-4 = 5mg/day Days 5-90 (or date of discharge, death, etc) = 2mg/day

Group Type: EXPERIMENTAL

Vitamin K

Intervention Type: DRUG

Administration of intravenous Vitamin K in doses of 10mg/day, 5mg/day or 2mg/day

Standard of Care Dose of Vitamin K

This group of patients will be reviewed retrospectively and would have received Vitamin K IV at 10mg/day during their entire hospital course

Group Type: ACTIVE_COMPARATOR

Vitamin K

Intervention Type: DRUG

Administration of intravenous Vitamin K in doses of 10mg/day, 5mg/day or 2mg/day

Interventions

Vitamin K

Administration of intravenous Vitamin K in doses of 10mg/day, 5mg/day or 2mg/day

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• The Subject:

1. is anticipated to be hospitalized for the duration of treatment.

2. is ≥18 years of age.

3. or their legally authorized representative is able to provide informed consent.

4. has been diagnosed with at least 20%TBSA thermal, chemical, or electrical burn.

5. has a negative urine or serum pregnancy test at screening (if female and has potential for pregnancy)?

6. is expected to receive the standard of care dosing of intravenous Vitamin K (10g/day).

Exclusion Criteria

• The Subject:

1. has a history or, or has present at baseline any of the following:

1. bleeding disorders

2. thrombocytopenia

3. coagulopathy

2. liver failure (MELD -Model for end stage liver disease score ≥20)

3. is already therapeutically anticoagulated for PE, DVT, etc.

4. is participating in another interventional clinical trial for the duration of the study.

5. is moribund, or in the opinion of the investigator is not expected to survive.

6. has a burn injury sustained as a result a suicide attempt.

Historical Cohort Inclusion/Exclusion All criteria will be the same except there will be no informed consent requirement. The data collection portion in the historical cohort will be to match burn size, type and etiologies and to collect lab results and other outcomes as specified in the study objectives. No PHI will be collected or shared. Additionally, only patients that received intravenous Vitamin K 10m/day for at least 14 days will be chosen for data collection. Every attempt will be made to match study drug duration (90days) as closely as possible.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Joseph M. Still Research Foundation, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Quinn, MD

Role: PRINCIPAL_INVESTIGATOR

Joseph M. Still Research Foundation, Inc.

Locations

Joseph M. Still Burn Center at Doctors Hospital

Augusta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Joan M Wilson, MSN, MHA, RN

Role: CONTACT

joan.wilson@jmsresearchfoundation.org

7063642966 ext. 7505

Tammy Taylor

Role: CONTACT

tammy.taylor@jmsresearchfoundation.org

7063642966 ext. 7501

Facility Contacts

Joan Wilson

Role: primary

joan.wilson@jmsresearchfoundation.org

706-364-2966 ext. 7063642966

Tammy Taylor

Role: backup

tammy.taylor@jmsresearchfoundation.org

7063642966 ext. 7063642966

References

Zittermann A. Effects of vitamin K on calcium and bone metabolism. Curr Opin Clin Nutr Metab Care. 2001 Nov;4(6):483-7. doi: 10.1097/00075197-200111000-00003.

Reference Type: BACKGROUND

PMID: 11706280 (View on PubMed)

Fulton RL, McMurdo ME, Hill A, Abboud RJ, Arnold GP, Struthers AD, Khan F, Vermeer C, Knapen MH, Drummen NE, Witham MD. Effect of Vitamin K on Vascular Health and Physical Function in Older People with Vascular Disease--A Randomised Controlled Trial. J Nutr Health Aging. 2016 Mar;20(3):325-33. doi: 10.1007/s12603-015-0619-4.

Reference Type: BACKGROUND

PMID: 26892582 (View on PubMed)

Yoshida M, Jacques PF, Meigs JB, Saltzman E, Shea MK, Gundberg C, Dawson-Hughes B, Dallal G, Booth SL. Effect of vitamin K supplementation on insulin resistance in older men and women. Diabetes Care. 2008 Nov;31(11):2092-6. doi: 10.2337/dc08-1204. Epub 2008 Aug 12.

Reference Type: BACKGROUND

PMID: 18697901 (View on PubMed)

Vitamin K Fact Sheet for health professionals. National Institutes of Health Office of Dietary Supplements. U. S. Department of Health and Human Services. Retrieved from https://olds.od.nih.gov/factsheets/VitaminK-HealthProfessional on January 16, 2019.

Reference Type: BACKGROUND

Other Identifiers

JMSRF-VITK-P01

Identifier Type: -

Identifier Source: org_study_id